Why
is it important to vaccinate against rotavirus? Isn't the disease
benign?

Before rotavirus vaccines were
available, rotavirus was the most common cause of severe
gastroenteritis in infants and young children in the United States and
worldwide. Almost all children were infected by age 5 years. Before
vaccine was introduced in the United States, rotavirus was responsible
each year for about 3 million episodes of gastroenteritis, 410,000
physician visits, 205,000272,000 emergency department visits,
55,00070,000 hospitalizations, and between 20 and 60 deaths among
children younger than age 5 years.

Is it possible for adults to contract
rotavirus? What are the symptoms in adults?

Yes. Rotavirus infection of adults is usually asymptomatic but may
cause diarrheal illness. Outbreaks of diarrheal illness caused by
rotavirus have been
reported, especially among elderly persons living in retirement
communities. For more information on this issue see MMWR 2011;60:1456.

What are the recommendations for use
of rotavirus vaccines?

Two rotavirus vaccines are available in the United States. RotaTeq
(Merck) is recommended for routine oral administration for all infants
as a 3-dose series.
The usual schedule is at ages 2, 4, and 6 months. Rotarix
(GlaxoSmithKline) is recommended as a 2-dose series at ages 2 and 4
months. ACIP recommendations
for use of rotavirus vaccines are available at www.cdc.gov/mmwr/preview/mmwrhtml/rr5802a1.htm.

The minimum age for the first dose is 6 weeks and the maximum age for
dose #1 is 14 weeks 6 days. Vaccination should not be initiated for
infants age 15
weeks 0 days or older because there are insufficient data on the
safety of dose #1 in older infants. The minimum interval between doses
of rotavirus vaccine
is 4 weeks. The maximum age for the last dose of rotavirus vaccine is
8 months and 0 days.

How do the two rotavirus vaccines
differ?

The two rotavirus vaccine products differ in composition and schedule
of administration. RotaTeq (RV5) contains five reassortant rotaviruses
developed from
human and bovine parent rotavirus strains; 3 doses are given in the
series. Rotarix (RV1) contains an attenuated human rotavirus strain; 2
doses are given in
the series.

Can RotaTeq (RV5; Merck) and Rotarix
(RV1; GlaxoSmithKline) vaccines be used interchangeably? If so, what
schedule should we follow?

ACIP recommends that the rotavirus vaccine series be completed with
the same product whenever possible. However, vaccination should not be
deferred because
the product used for a previous dose is not available or is unknown.
In these situations, the provider should continue or complete the
series with the
product available. If any dose in the series was RV5, or the vaccine
product is unknown for any dose in the series, a total of 3 doses of
rotavirus vaccine
should be administered. The minimum interval between doses of
rotavirus vaccine is 4 weeks. All doses should be administered by age
8 months and 0 days.

If we don't know which rotavirus
vaccine an infant previously received, how should we complete the
schedule?

If the product used for a previous dose is unknown, and the infant is
at an age when the vaccine can still be given, give a total of 3 doses
of rotavirus
vaccine. All doses should be administered by age 8 months and 0 days.

If the first dose of rotavirus vaccine
is inadvertently given to a child age 15 weeks 0 days or older, should
the series be continued?

Infants for whom the first dose of rotavirus vaccine was inadvertently
administered at age 15 weeks or older should receive the remaining
doses of the series
at the routinely recommended intervals. Timing of the first dose
should not affect the safety and efficacy of the remaining doses.
Rotavirus vaccine should
not be given after age 8 months 0 days even if the series is
incomplete.

Our experience has been that many
babies who receive the oral rotavirus vaccine spit a lot of it out. We
know not to give them more. But how can we be sure
that the little they ingest is enough?

Try to follow general guidelines for oral administration of liquid
vaccines. First, give this vaccine at the beginning of the office
visit, while the baby is
still happy, and before you administer injections or perform other
procedures. Second, make every effort to aim the dropper containing
the vaccine down one
side and toward the back of the child's mouth. Don't put the dropper
so far back that you gag the child. You may find the following
information from the
RotaTeq manufacturer helpful: www.merckvaccines.com/Products/RotaTeq/Pages/dosageandadministration. You can also find a pictorial description of
both reconstitution and administration of Rotarix in the package
insert at http://us.gsk.com/products/assets/us_rotarix.pdf.

Can rotavirus vaccine be given via
G-Tube? If so, is it okay to flush with normal saline or sterile
water?

The manufacturer has not addressed this issue but CDC considers
administration of rotavirus vaccine via gastrostomy tube to be
acceptable practice. There
should be no problem flushing the tube after vaccine has been
administered.

A child received the first rotavirus
vaccine and after a while he got the disease (laboratory confirmed).
Should we continue the vaccine?

ACIP recommends that infants who have had rotavirus gastroenteritis
before receiving the full series of rotavirus vaccination should still
start or complete
the schedule according to the age and interval recommendations because
the initial rotavirus infection might provide only partial protection
against
subsequent rotavirus disease.

Should we warn parents/guardians to
wash their hands after diaper changes, which they should be doing
anyway, after the baby has received rotavirus vaccine?

Yes. Rotavirus vaccine virus is shed during the first weeks after
administration of rotavirus vaccine. Handwashing after diaper changing
is always
recommended.

Which infants should not receive
rotavirus vaccine?

Do not give rotavirus vaccine to an infant who has a history of a
severe allergic reaction (for example, anaphylaxis) after a previous dose of
rotavirus vaccine or
to a vaccine component. The oral applicator for Rotarix contains latex
rubber so infants with a severe (anaphylactic) allergy to latex should
not be given
Rotarix; the RotaTeq dosing tube is latex-free. Rotavirus vaccine is
contraindicated in infants diagnosed with the rare disorder, severe
combined
immunodeficiency (SCID) and infants with a history of intussusception.

Can rotavirus vaccine be given to an
infant who has an immunosuppressed household contact?

Having an immunocompromised household contact is not usually a reason
for delaying routine vaccination for others in the household.
Rotavirus vaccine should
be administered to susceptible household contacts and other close
contacts of immunocompromised patients when indicated. All members of
the household should
wash their hands after changing the diaper of an infant. This
minimizes rotavirus transmission from an infant who received rotavirus
vaccine. Additional
information on this topic can be found in the ACIP General
Recommendations on Immunization, available at www.cdc.gov/mmwr/pdf/rr/rr6002.pdf.

Can preterm infants receive rotavirus
vaccine?

ACIP supports vaccination of preterm infants according to the same
schedule and precautions as full-term infants and under the following
conditions: if the
infant's chronological age meets the age requirements for rotavirus
vaccine (for example, age 6 weeks to 14 weeks 6 days for dose #1), the infant
is clinically
stable, and the vaccine is administered at the time of discharge from
the hospital or after discharge from the hospital.

Have these vaccines (RotaTeq or
Rotarix) been associated with intussusception?

Large prelicensure clinical trials of both RotaTeq and Rotarix did not
find an increased risk for intussusception among vaccine recipients. A
large
postlicensure study of more than 1.2 million rotavirus vaccine
recipients found a very small increased risk of intussusception (1 to
1.5 additional cases of
intussusception per 100,000 vaccinated infants) in the 7 to 21 days
following the first dose. No increased risk of intussusception was
found after the second
or third doses. CDC and the Food and Drug Administration (FDA)
continue to believe that the benefits of rotavirus vaccination
outweigh the risks associated
with vaccination and that routine vaccination of infants should
continue. Additional information on this topic can be found on the FDA
website at www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ucm356758.htm.

A study conducted by the CDC Vaccine
Safety Datalink (VSD) between May 2006 to February 2010 found no
increased risk of intussusception following vaccination
with RotaTeq. However, the study indicated an increased risk of
intussusception following dose 1 and dose 2 of Rotarix. Over 200,000
doses of Rotarix have
been given to children monitored in VSD. Based on these findings, one
case of intussusception would be expected for approximately each
20,000 children, who
are fully vaccinated.

According to the package inserts the
maximum age for a dose of RotaTeq is 32 weeks and the maximum age for
Rotarix is 24 weeks. According to ACIP
recommendations the maximum age for a dose of rotavirus vaccine is 8
months 0 days. Eight months 0 days is older than age 24 weeks and may
be older than age
32 weeks. Should I follow the package labels or the ACIP
recommendation?

ACIP recommendations and package inserts do not always match.
Occasionally, ACIP may use different data to formulate its
recommendations, or try to add
flexibility to its recommendations (as was the case in this
situation), which results in a recommendation different than the
package insert. Published
recommendations of national advisory groups (such as ACIP or AAP's
Committee on Infectious Diseases) should be considered equally as
authoritative as those
on the package insert. You should consider 8 months 0 days as the
maximum age for a dose of rotavirus vaccine.

What are the storage and handling
guidelines for rotavirus vaccine (RotaTeq and Rotarix)?

Both vaccines should be stored at refrigerator temperature and
protected from light. Do not administer the vaccine if it has been
frozen or exposed to
freezing temperatures.

This website is supported in part by a cooperative agreement from the National Center for Immunization and Respiratory Diseases (Grant No. 5U38IP000290) at the Centers for Disease Control and Prevention (CDC) in Atlanta, GA. The website content is the sole responsibility of IAC and does not necessarily represent the official views of CDC.